ABSTRACT
Introducción: Los tratamientos insulínicos actuales para diabetes tipo 1 (DM1) no siempre consiguen los objetivos de control metabólico debido, entre otros aspectos, a la aparición de episodios de hipoglucemia asociados al uso de insulina. Material y métodos: Estudio descriptivo en la vida real con 247 pacientes DM1, el 55,5% varones, de 46,53 ± 16,23 años, con un tiempo de evolución de 21,89 ± 11,99 años, a los que se sustituyó su insulina basal, glargina U100, por glargina U300. Los objetivos primarios fueron los cambios en la HbA1c y en el número de hipoglucemias y los secundarios fueron los cambios en el peso y en la dosis de insulina trascurridos 6 y 12 meses. Resultados: Tras un año, no se observaron cambios en la HbA1c en el total de los pacientes, si bien se comprobó un descenso significativo en los pacientes mal controlados. Sin embargo, aumentó el porcentaje de pacientes con HbA1c < 7,5% a los 6 meses (33,5 vs. 40,5%; p < 0,05), que se mantuvo al año. El número de hipoglucemias leves se redujo tras los 12 meses de tratamiento en aquellos pacientes con antecedentes de hipoglucemias leves. En cuanto al peso, no observamos cambios. La dosis total de insulina/kg se incrementó significativamente en un 7,24% a los 6 meses y en un 8,69% al año por el aumento de la insulina basal. Las diferencias en las dosis a los 6 meses y al año no fueron significativas. Este aumento fue similar entre los grupos según el control metabólico, la presencia de hipoglucemias y no se relacionó con la insulina basal inicial, la HbA1c inicial, el número de hipoglucemias leves ni con el peso inicial. Discusión: En la vida real glargina U300 muestra un mejor control glucémico en pacientes mal controlados, al reducir las hipoglucemias en pacientes con antecedentes de hipoglucemias sin incrementar el peso corporal
Introduction: Current treatment of type 1 diabetes mellitus (T1DM) does not always achieve metabolic control because, among other things, the ocurrence of hypoglycemic events associated to insulin use. Material and methods: A descriptive real life study of 247 T1DM patients, 55.5% male, aged 46.53 ± 16.23 years, and with a mean diabetes duration of 21.89 ± 11.99 years, who were switched from basal insulin glargine U100 to glargine U300. The primary endpoints were changes in Hba1c and number of hypoglycemic events, while secondary endpoints included changes in weight and insulin dose after 6 and 12 months. Results: After one year, no changes were seen in HbA1c, but the proportion of patients with HbA1c values <7.5% increased at 6 months (33.5 vs. 40.5%; P<0.05) and remained stable during one year of follow-up. Hypoglycemic events significantly decreased after one year of treatment in patients with previous hypoglycemic events. No changes were seen in body weight. Total insulin dose (U/kg) increased 7.24% at 6 months of treatment and by 8.69% at one year, mainly due to basal insulin. No changes were seen between the doses given at 6 and 12 months. These changes were similar in the different metabolic control groups and in patients with or without hypoglycemia. This increase was not related with prior basal insulin dose, baseline HbA1c level, number of hypoglycemic events or baseline weight. Discussion: Glargine U300 is a good basal insulin alternative to treat T1DM, improving metabolic control in patients with HbA1c levels >7,5 and decreasing hypoglycemic events in patients with history of hypoglycemia without increasing body weight
Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Diabetes Mellitus, Type 1/drug therapy , Insulin Glargine/administration & dosage , Hypoglycemic Agents/administration & dosage , Retrospective Studies , Body Weight/radiation effects , Treatment Outcome , Follow-Up StudiesABSTRACT
INTRODUCTION: Current treatment of type 1 diabetes mellitus (T1DM) does not always achieve metabolic control because, among other things, the ocurrence of hypoglycemic events associated to insulin use. MATERIAL AND METHODS: A descriptive real life study of 247 T1DM patients, 55.5% male, aged 46.53 ± 16.23 years, and with a mean diabetes duration of 21.89 ± 11.99 years, who were switched from basal insulin glargine U100 to glargine U300. The primary endpoints were changes in Hba1c and number of hypoglycemic events, while secondary endpoints included changes in weight and insulin dose after 6 and 12 months. RESULTS: After one year, no changes were seen in HbA1c, but the proportion of patients with HbA1c values <7.5% increased at 6 months (33.5 vs. 40.5%; P<0.05) and remained stable during one year of follow-up. Hypoglycemic events significantly decreased after one year of treatment in patients with previous hypoglycemic events. No changes were seen in body weight. Total insulin dose (U/kg) increased 7.24% at 6 months of treatment and by 8.69% at one year, mainly due to basal insulin. No changes were seen between the doses given at 6 and 12 months. These changes were similar in the different metabolic control groups and in patients with or without hypoglycemia. This increase was not related with prior basal insulin dose, baseline HbA1c level, number of hypoglycemic events or baseline weight. DISCUSSION: Glargine U300 is a good basal insulin alternative to treat T1DM, improving metabolic control in patients with HbA1c levels >7,5 and decreasing hypoglycemic events in patients with history of hypoglycemia without increasing body weight.
